A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants

NCT07044271 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27282J3M-OX-JZQK
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib

  PK: AUC(0-tlast) of Olomorasib

  From Day 1, Predose up to 72 hours Postdose

• PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib

  PK: AUC(0-∞) of Olomorasib

  From Day 1, Predose up to 72 hours Postdose

• PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib

  PK: Cmax of Olomorasib

  From Day 1, Predose up to 72 hours Postdose

Study Arms (3)

Olomorasib - (Test Formulation 1)

EXPERIMENTAL

Olomorasib administered orally

Drug: Olomorasib

Olomorasib - (Test Formulation 2)

EXPERIMENTAL

Olomorasib administered orally

Drug: Olomorasib

Olomorasib - (Reference Formulation)

ACTIVE COMPARATOR

Olomorasib administered orally

Drug: Olomorasib

Interventions

Olomorasib DRUG

Single dose

Also known as: LY3537982

Olomorasib - (Reference Formulation); Olomorasib - (Test Formulation 1); Olomorasib - (Test Formulation 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
• Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
• Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).

You may not qualify if:

• Females who are lactating or of childbearing potential
• Clinically significant history of any drug sensitivity, drug allergy, or food allergy
• Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

RECRUITING

ICON

Salt Lake City, Utah, 84124, United States

RECRUITING

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-way crossover study

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: June 29, 2025
• Study Start: July 11, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)